Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month

13 August, 2017, 01:06 | Author: Wilson Dawson
  • Five Die While Using Obesity Devices, FDA Says

The FDA said that it has not yet determined whether the weight loss devices or the surgery that implanted them is the cause of the deaths, but it had already issued an alert so doctors would closely monitor patients who have them.

The FDA issued an update to alert healthcare providers of 5 deaths that occurred since 2016 in patients with liquid-filled stomach balloons.

One of the devices is a balloon that can be placed in the stomach and filled with saline water, the Orbera balloon made by Apollo Endo-Surgery. Both systems can be placed in the stomach for up to 6 months to help obese people lose weight.

"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the US clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website.

The FDA has not identified a root cause for the patient deaths and can not "definitively attribute the deaths to the devices or the insertion procedures for these devices", according to an agency notice.

Four of the reported deaths involved the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one other death involved the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc., the FDA said in a press release.


The FDA said it is not clear whether the deaths were caused by the devices - which were approved in 2015 - or the surgical process.

The FDA is also investigating two other deaths, one from each company, due to "potential complications associated with balloon treatment.". One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System.

"Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously", said Apollo Endosurgery CEO Todd Newton in a statement.

All five patient deaths occurred within a month of balloon placement, and three happened just one to three days after the procedure.

Last year America expended $2.5 billion on commercial weight-loss balloons.

"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the US clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website.

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